Daniel Hines noted that virtually all medicines sold in the US are manufactured outside of this country, and that access to safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One countries—those with standards of efficacy and oversight that meet or exceed those of the U.S.—provides the only relief for vast numbers of Americans who must either pay the highest costs for prescription medicines in the world, or choose to do without their vital, often life-saving medicines.
“The US is a safe-haven for the highest prescription medicine prices in the world, which is the reason that millions of Americans have turned to personal importation as a vital lifeline to their medicines—the very same medicines sold in the US at prices as much as 60 percent higher,” Hines explains.
“The actions of the FDA to establish reciprocity with regulatory agencies in countries outside the U.S. is an admission by the FDA that such cooperative arrangements can be accepted as providing the oversight that will validate the safety and efficacy of not only ingredient manufacture but of pharmacies, as so many advocates on behalf of personal importation have urged,” Hines says.
“The problem is that, by confusing in the minds of the American public, bogus pharmacies with personal importation that has a proven record of safety and efficacy built by providing vital medicines to Americans for many years there could be unintended consequences adversely affecting the health and well-being of millions of Americans.”
While lauding the stated intent of a new FDA website ostensibly designed to help patients identify bogus, illegal pharmacies issuing counterfeit medicines as “an admirable goal”, he notes that “by limiting its ‘acceptable’
“In a recent interview, a Consumer Reports spokesperson described bogus pharmacies as being ‘like gopher holes that pop up everywhere even after being shut down.’
“That is why we urge the FDA to recognize that it might adversely affect legitimate and safe sources of medicines, forcing untold numbers of Americans to either curtail their vital medicines because they are unaffordable in the US—or, more troublesome, leaving only bogus pharmacies to which unknowing patients might unwittingly turn.
“The result with be an endangerment of the health and well-being of huge numbers of Americans. And therein lies the unintended consequences in which good motives go wrong, “ Hines says.
He identifies three steps that the FDA should take to remedy this dilemma:
• The Secretary of Health and Human Services should direct the FDA to extend its policy of reciprocity regarding manufacture of ingredients and medicines with regulatory agencies of other countries by exploration of processes to identify those pharmacies that are licensed and reputable;
• In light of repeated favorable votes in favor of personal importation, Congress should also direct that the FDA as a matter of public policy extend the policy of reciprocity to personal importation;
• The FDA should clearly identify to Congress and the American public clearly identifiable bogus pharmacies, and its strategies to deter their access to selling counterfeit medicines;
“Such actions will be a clear sign that the health and well-being of Americans is a primary goal of the FDA,” Hines concludes. “It will also be a clear signal to Pharma that the FDA recognizes that the cost of prescription medicines in the US is a major driver of healthcare costs, and without clarification of the beneficial impact of personal importation upon American’s physical and financial health, the limitations of the new website will indeed have unintended and adverse consequences.”